Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer

Completed · Phase 2

Conditions studied: Colon Adenocarcinoma, Rectal Adenocarcinoma, Stage III Colorectal Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7

In brief

This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid cream that is commonly used to treat a variety of skin conditions and may help prevent hand-foot skin reactions in patients receiving regorafenib.

Key facts

Study ID

NCT02368886

Run by

Academic and Community Cancer Research United

People needed

123

Starts

2015-03-27

Expected to finish

2023-03-02

Last updated by the study team

2025-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological documentation of adenocarcinoma of the colon or rectum
• Advanced or metastatic colorectal cancer with no curative options available and progression on previous standard therapy, including an EGFR inhibitor if KRAS wild-type
• Measurable or non-measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Life expectancy of >= 3 months
• Absolute neutrophil count (ANC) > 1500/mm\^3 (obtained =< 7 days prior to randomization)
• Platelet count > 100,000/mm\^3 (obtained =< 7 days prior to randomization)
• Hemoglobin > 9.0 g/dL (obtained =< 7 days prior to randomization)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to randomization)
• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to randomization)
• Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to randomization)
• International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN (obtained =< 7 days prior to randomization)
• NOTE: patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care
• Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement of their cancer) (obtained =< 7 days prior to randomization)
• Negative serum pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only; note: post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
• Ability to complete questionnaire(s) by themselves or with assistance
• Provide informed written consent
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Willing to provide blood samples for correlative research and banking purposes

You may not qualify if…

• Prior treatment with regorafenib
• Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to randomization
• Congestive heart failure > New York Heart Association (NYHA) class 2
• Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 6 months prior to randomization
• Cardiac arrhythmias requiring anti-arrhythmic therapy; Note: pace makers, beta blockers, or digoxin are permitted
• Uncontrolled hypertension; (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
• History of or current pheochromocytoma
• Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism =< 6 months prior to randomization
• Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• Known history of chronic hepatitis B or C
• Patients with seizure disorder requiring medication
• Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization; note: patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
• History of organ allograft (including corneal transplant)
• Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE grade 3 =< 4 weeks prior to randomization
• Non-healing wound, ulcer, or bone fracture
• Renal failure requiring hematological (hemo-) or peritoneal dialysis
• Dehydration CTCAE (version 4.0) grade >= 1
• Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results
• Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
• Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
• Persistent proteinuria of Common Toxicity Criteria (CTC) grade 3 or higher (>= 3.5 g/24 hours [hrs])
• Patients unable to swallow oral medications
• Any malabsorption condition
• Unresolved toxicity greater than CTCAE (version 4.0) grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity =< grade 2
• Albumin levels < 2.5 g/dl

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Siouxland Regional Cancer Center — Sioux City, Iowa, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Hematology Oncology Associates of Central New York-East Syracuse — East Syracuse, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Toledo Clinic Cancer Centers-Toledo — Toledo, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Wellmont Medical Associates Oncology and Hematology-Kingsport — Kingsport, Tennessee, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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